- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00567203
A Study Of Adjunctive Treatment Of Cognitive Deficits In Schizophrenia
October 1, 2008 updated by: Pfizer
A Phase 1B Inpatient, Randomized, Double-Blind, Placebo-Controlled, Crossover Study Of The Safety And Efficacy Of Two Fixed Doses Of PF-3463275 In Adjunctive Treatment Of Cognitive Deficits In Schizophrenia
The objective of this study is to evaluate the safety, tolerability, and efficacy of two dose regimens of PF-3463275 compared with placebo added to ongoing atypical antipsychotic therapy for cognitive deficits in subjects with chronic symptoms of schizophrenia.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Glendale, California, United States, 91206
- Pfizer Investigational Site
-
-
New Jersey
-
Willingboro, New Jersey, United States, 08046
- Pfizer Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of schizophrenia
- In stable treatment with risperidone, olanzapine, quetiapine, ziprasidone, aripiprazole, or paliperidone for at least 2 months
- Stable symptoms of schizophrenia for at least 3 months.
Exclusion Criteria:
- Subjects with a psychiatric disorder other than schizophrenia
- Substance dependence or abuse
- Women who have child bearing potential.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
PF-3463275 10mg
PF-3463275 25mg
|
Experimental: 2
|
PF-3463275 10mg
PF-3463275 25mg
|
Placebo Comparator: 3
|
Placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in the CNS Vital Signs Cognition Battery composite score
Time Frame: 6 days
|
6 days
|
Safety Endpoints: tolerability, laboratory tests, vital signs, and ECG's.
Time Frame: 38 days
|
38 days
|
Pharmacokinetics of PF-3463275
Time Frame: 6 days
|
6 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Positive and Negative Syndrome Scale (PANSS)
Time Frame: 6 days
|
6 days
|
Change from baseline in the CNS Vital Signs Cognition Battery domain scores
Time Frame: 6 days
|
6 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2007
Primary Completion (Actual)
May 1, 2008
Study Completion (Actual)
May 1, 2008
Study Registration Dates
First Submitted
December 3, 2007
First Submitted That Met QC Criteria
December 3, 2007
First Posted (Estimate)
December 4, 2007
Study Record Updates
Last Update Posted (Estimate)
October 2, 2008
Last Update Submitted That Met QC Criteria
October 1, 2008
Last Verified
October 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A9131004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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